UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of effects of bronchial thermoplasty on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Title of the study (Brief title)	Examination of effects of bronchial BT on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Region	Japan

Condition
Condition	severe refractory asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine the efficaecy of BT on mediators in the respiratory tract, exercise induced asthma, asthma control and QOL and confirmation of safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Decrease rate of FEV 1 before and after exercise load at 52 weeks after the last BT
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	BT is performed at least three weeks apart, and preformed three times in tota
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult (over 20 years) patients with severe refractory asthma who require regular maintenance medications of inhaled corticosteroids and a long-acting beta agonist.
Key exclusion criteria	Patients with BT contraindicated Patients incapable of general anesthesia Patients whose exercise stress test is considered contraindicated
Target sample size	10

Research contact person
Name of lead principal investigator	Johsuke Hara
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2000
Email	hara0728@gmail.com

Public contact
Name of contact person	Johsuke Hara
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2000
Homepage URL
Email	hara0728@gmail.com

Sponsor
Institute	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Metabolomics Medical Institute of Bioregulation Kyushu University
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 16 Day
Last modified on	2017 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030516